MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 NEUT 32IDX62OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Model Number	1218-32-662
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Surgeon revised a total hip replacement after the patient had a fall and dislocated his hip.The liner was constrained and had broken insitu.When surgeon was trying to put the metal reinforcement ring over the constrained poly, it cracked.He removed it and had to use another one.Doi: unknown, dor: (b)(6) 2021, unknown side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received states that the instrument was broken into 2 pieces.All pieces were retrieved from the patient.

• Brand Name: PINN LNR CON +4 NEUT 32IDX62OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12347503
• Report Number: 1818910-2021-18235
• Device Sequence Number: 4496929
• Product Code: KWZ
• UDI-Device Identifier: 10603295011910
• UDI-Public: 10603295011910
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1218-32-662
• Device Catalogue Number: 121832662
• Device Lot Number: J0481K
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 09/29/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/15/2021; 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PINN LNR CON +4 NEUT 40IDX62OD.; UNK HIP LOCKING RING.; UNKNOWN HIP FEMORAL HEAD.